Casdatifan

AstraZeneca (LSE/STO/NYSE: AZN) is discontinuing the eVOLVE-Lung02 Phase III trial after an Independent Data Monitoring Committee (IDMC) concluded that volrustomig plus chemotherapy was unlikely to meet either of its dual primary endpoints — progression-free survival (PFS) or overall survival (OS) — in patients with PD-L1-negative metastatic non-small cell lung cancer (mNSCLC). The trial enrolled 895 patients across 25 countries and was designed to beat Merck's Keytruda (pembrolizumab) plus chemotherapy in a population where immunotherapy delivers its least durable benefit. The failure is a direct setback for AstraZeneca's ambition to establish volrustomig as a superior first-line option for the mNSCLC patients with low or absent PD-L1 expression. The PD-L1 <1% subgroup — the primary analysis population — is widely regarded as the hardest to treat with existing checkpoint inhibitors, and the rationale for testing a dual-checkpoint bispecific in this setting was mechanistically coherent: volrustomig is engineered to simultaneously block PD-1 and CTLA-4 on the same activated T cell, concentrating CTLA-4 inhibition where it is most needed while sparing resting peripheral T cells. The IDMC's futility call suggests that coordinated dual blockade on the same T cell did not translate into a survival advantage over pembrolizumab plus chemotherapy in this population. No numerical efficacy data were disclosed. AstraZeneca said the safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual agents, with no new safety signals identified. The 895-patient trial randomized patients to volrustomig plus chemotherapy or pembrolizumab plus chemotherapy, followed by maintenance with the respective checkpoint inhibitor. Secondary endpoints covered PFS and OS in the broader intent-to-treat population (PD-L1 <50%), but the IDMC's recommendation was based on futility in the PD-L1 <1% primary analysis population. The result adds to recent difficulty in improving on pembrolizumab-based regimens in first-line NSCLC. Immutep discontinued the Phase III TACTI-004 trial of LAG-3 agonist eftilagimod alfa plus pembrolizumab and chemotherapy in first-line NSCLC in March 2026 after an interim futility analysis. Bristol Myers Squibb's Opdivo (nivolumab) plus Yervoy (ipilimumab) with chemotherapy remains approved in this population, as does AstraZeneca's own Imjudo (tremelimumab) plus Imfinzi (durvalumab) plus chemotherapy — the latter approved in November 2022 under the POSEIDON regimen. The eVOLVE-Lung02 result raises questions about whether a bispecific format delivering simultaneous PD-1/CTLA-4 blockade on the same T cell offers a clinically meaningful advantage over sequential or separate checkpoint combinations in the chemotherapy-combination setting. AstraZeneca said three other Phase III volrustomig trials continue as planned: eVOLVE-Cervical in high-risk locally advanced cervical cancer, eVOLVE-HNSCC in unresected locally advanced head and neck squamous cell carcinoma following chemoradiotherapy, and eVOLVE-Meso in unresectable malignant pleural mesothelioma. Volrustomig is also being evaluated in combination with Arcus Biosciences' casdatifan in first-line clear cell renal cell carcinoma under the eVOLVE-RCC02 study, which AstraZeneca is operationalizing. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today announced that the Compensation Committee of the Company’s Board of Directors granted one new employee options to purchase a total of 2,850 shares of the Company’s common stock at an exercise price per share of $28.72, which was the closing price on August 10, 2026, and restricted stock units to acquire a total of 1,450 shares of the Company’s common stock. The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the “inducement exception” under NYSE Listed Company Manual Rule 303A.08. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit . Inducement PR ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Source: Arcus Biosciences Contacts Investor Inquiries: Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri Director of Corporate Affairs (510) 406-8520 mbassiri@arcusbio.com